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Clinical Trials/NCT04162288
NCT04162288
Completed
Not Applicable

RCT Protocol for Evaluating an Online Training Program on Shared Decision-making About Screening for Down Syndrome

CHU de Quebec-Universite Laval1 site in 1 country36 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shared Decision Making
Sponsor
CHU de Quebec-Universite Laval
Enrollment
36
Locations
1
Primary Endpoint
Change of intention to use a decision aid after completing the online training program on SDM in prenatal screening
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The investigators aim to evaluate an online training program on shared decision making within the prenatal context. The main outcome is intention on using a decision aid in prenatal screening consultation and study population is nurses. Secondary outcomes are; knowledge acquisition, acceptability of the formation and perceived usefulness. The investigators hypothesise that this web-based SDM training program developed for the prenatal screening of Down Syndrome will significantly increase nurses' intentions to use the decision aid in their clinical practice with pregnant women and their partner.

Detailed Description

Pregnant women have difficulty choosing among the wide variety of prenatal screening options available. To help pregnant women and their partners make informed decisions based on their values, needs and preferences, a decision aid (DA) has been developped and online shared decision-making (SDM) training program for health professionals has been created to support the use of this DA and give health care professionals key elements on SDM. The decision aid was found relevant and acceptable to pregnant women and their partners; the relevance and acceptability of the online SDM training program aren't evaluated yet. This study aim to assess the intention on using a DA after taking the online training program, to evaluate knowledge acquisition and to assess the program's acceptability and perceived usefulness. This is a multi-center, two-arm, controlled trial (RCT). Thirty-six participants will be randomly allocated to either 1) an experimental group that is exposed to the investigator's complete 3 hours online training program intervention (n = 18) or 2) a control group that is exposed to an intervention which will be a 3 hours online training program focused on prenatal screening alone.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
January 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CHU de Quebec-Universite Laval
Responsible Party
Principal Investigator
Principal Investigator

France Legare

Principal investigator

CHU de Quebec-Universite Laval

Eligibility Criteria

Inclusion Criteria

  • Be a certified nurse
  • Be involved in supporting prenatal screening decision-making or involved in prenatal screening processes in the province of Quebec;
  • Speak and write in French
  • Being in active practice within the last year.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change of intention to use a decision aid after completing the online training program on SDM in prenatal screening

Time Frame: The intention will be measured initially before accessing the formation. After the formation completed (duration is variable), the participant will have access to the questionnaire once again in a delay of 24-72 hours.

Nurses intention of using a decision aid for prenatal screening in clinical practice is the primary outcome. To be measured, the CPD (Continuing professional development) reaction questionnaire will be used. This questionaire scores on 5 constructs; intention, social influence, beliefs about capabilities, moral norm and beliefs about consequences and has 12 questions. The constructs intention will be targeted, however the others constructs will be also evaluated for their potential on predicting behavior of health professionals. It is a self-reported questionnaire. The use of decision aid has been chosen as an outcome become it is a main component of SDM itself and of the training. The score is on a scale from 1 to 7 (Likert type), which 1 is the minimum and 7 the maximum value (except one question that has a 5 intervals of pourcentage, that will be adjusted on 7 items scale in the analysis). The higher score means better outcome.

Secondary Outcomes

  • Knowledge on aspects surrounding prenatal screening and SDM(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)
  • Perceived usefulness(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)
  • Satisfaction with training: self-reported questionnaire(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)
  • Acceptability of the training: self-reported questionnaire(After the formation completed (duration is variable), the participant will have access to the questionnaire in a delay of 24-72 hours.)

Study Sites (1)

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